Obstructive Sleep Apnea, Resistant Hypertension
Conditions
Keywords
Resistant Hypertension, Obstructive Sleep Apnea, 24 Hour Blood Pressure, Arterial Stiffness, Insulin Resistance, CPAP, APAP
Brief summary
The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA). The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.
Detailed description
The confirmatory hypothesis is that subjects with resistant hypertension and OSA will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed CPAP in comparison to those treated with APAP. Explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed CPAP than APAP.
Interventions
DEVICECPAP
6 weeks treatment with fixed CPAP
DEVICEAPAP
6 weeks of treatment with auto-titrating positive airway pressure
Sponsors
OSR Medical Inc.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Resistant Hypertension * Moderate Obstructive Sleep Apnea
Exclusion criteria
* Creatinine \>150 μmol/l * Systolic blood pressure \> 170 mmHg * Diastolic blood pressure \> 105 mmHg * Secondary cause of hypertension other than OSA * Treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder * Current treatment or recent treatment within the last 3 months for any other medical condition which has resulted or would be expected to result in a change in blood pressure medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hour blood pressure. | 6 weeks and 12 weeks after initial intervention |
Secondary
| Measure | Time frame |
|---|---|
| Non-invasive measures of arterial stiffness using applanation tonometry. | 6 weeks and 12 weeks after initial intervention |
| Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography. | 6 weeks and 12 weeks after initial intervention |
| Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin. | 6 weeks and 12 weeks after initial intervention |
Countries
Canada
Outcome results
None listed